A new item on CDER's 2026 guidance agenda, 'AI/ML Quality Considerations in Pharmaceutical Manufacturing,' aims to set validation and audit-trail standards for…
Roughly half of American adults take a daily supplement. In 2026, researchers made real progress on whether multivitamins work, even as federal…
A general wellness policy update continues the agency's multi-year pullback from regulating fitness trackers and AI-enabled wearables as medical devices.
Digital Health Center of Excellence director Rick Abramson says the agency will issue both broad and topic-specific rules as the industry waits…